Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Favorable Functional Outcome at 90 Days
研究概览
简要总结
ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits.
Eligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design).
Secondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.
详细描述
Stroke unit treatment in Germany is currently organized as multi-day inpatient care regardless of stroke severity. However, a substantial proportion of patients with acute ischemic stroke or transient ischemic attack present with non-disabling or fully regressed neurological deficits and may not require prolonged inpatient monitoring. At the same time, demographic changes and increasing stroke incidence in older populations challenge inpatient stroke unit capacity and resource allocation.
International experience with structured outpatient TIA and minor stroke clinics suggests that ambulatory management models may provide comparable clinical safety while reducing hospital utilization. However, randomized evidence for such models within the German healthcare system is lacking.
The ARTIFICE trial evaluates a structured ambulatory stroke unit care model designed to provide comprehensive same-day multiprofessional assessment and initiation of secondary prevention while maintaining patient safety. The study investigates whether this ambulatory care approach can represent a medically safe and resource-efficient alternative to conventional inpatient stroke unit treatment in selected older patients.
In addition to clinical effectiveness, the study examines patient-reported outcomes, healthcare utilization, cost-effectiveness, and implementation aspects to inform future health services planning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open-label study due to the nature of the care setting. Outcome assessment at 90 days is performed by independent study personnel who are blinded to treatment allocation (PROBE design).
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.*)
- •Symptom onset ≤ 7 days before enrollment
- •No or non-disabling newly occurring neurological deficit allowing safe ambulatory management
- •Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative
排除标准
- •Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
- •Fluctuating stroke symptoms within the previous 48 hours
- •Acute febrile infection or isolation-requiring infectious disease
- •Clinically relevant dysphagia with high aspiration risk
- •Critical medical or nursing findings requiring mandatory multi-day inpatient treatment
- •Palliative care situation with limitation of acute diagnostic or therapeutic measures
- •Previous participation in the ambulatory stroke unit care model
- •No statutory health insurance coverage in Germany
- •Insufficient German language proficiency to understand study procedures and assessments
研究组 & 干预措施
Ambulatory Stroke Unit Care (aSU)
Participants receive structured ambulatory stroke unit care consisting of comprehensive same-day multiprofessional assessment, diagnostic evaluation, and initiation of secondary prevention. After evaluation, clinically stable participants are discharged home with structured follow-up.
干预措施: Ambulatory Stroke Unit Care (Other)
Inpatient Stroke Unit Care (SU)
Participants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission.
干预措施: Conventional Stroke Unit Care (Other)
结局指标
主要结局
Favorable Functional Outcome at 90 Days
时间窗: 90 days (±14 days) after randomization
Favorable functional outcome defined as modified Rankin Scale (mRS) score 0-2 or return to pre-stroke mRS level, assessed by blinded outcome assessors.
次要结局
- Mobility(Baseline and 90 days)
- Health-Related Quality of Life(Baseline and 90 days)
- Healthcare Utilization(Up to 90 days after randomization)
- Serious Adverse Events(Up to 90 days after randomization)
- Stroke Impact(Baseline and 90 days)
- Early Neurological Deterioration(Within 7 days after randomization)
- Recurrent Stroke(Up to 90 days after randomization (primary safety observation period))
- Delirium Occurrence(Within 7 days after randomization)
- All-Cause Mortality(90 days and 12 months after randomization)
- Functional Status(Baseline and 90 days)
研究者
Dr. Jan Christoph Purrucker
Prof. Dr. Jan Purrucker
University Hospital Heidelberg